Trial Outcomes & Findings for Restylane Defyne in a Stepwise Treatment Approach (NCT NCT04520997)
NCT ID: NCT04520997
Last Updated: 2023-04-14
Results Overview
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 3 were reported.
COMPLETED
NA
62 participants
At Week 3
2023-04-14
Participant Flow
The study was conducted at 2 sites each in Brazil and Unites States,1 site in Italy from 07 Dec 2020 to 15 Sept 2021.
Participant milestones
| Measure |
Down-up
Participants in this group received injections in the chin and surrounding area with up to 2 milliliters (mL) Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the nasolabial folds (NLFs) and marionette lines (MLs) with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Top-down
Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
|
Overall Study
Treated
|
31
|
29
|
|
Overall Study
Safety Population
|
32
|
29
|
|
Overall Study
MITT (Modified Intention-to-treat) Population
|
31
|
29
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Down-up
Participants in this group received injections in the chin and surrounding area with up to 2 milliliters (mL) Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the nasolabial folds (NLFs) and marionette lines (MLs) with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Top-down
Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Not Treated
|
0
|
1
|
Baseline Characteristics
Restylane Defyne in a Stepwise Treatment Approach
Baseline characteristics by cohort
| Measure |
Down-up
n=31 Participants
Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Top-down
n=29 Participants
Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Types
Type I
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Skin Types
Type II
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Fitzpatrick Skin Types
Type III
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Fitzpatrick Skin Types
Type IV
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Fitzpatrick Skin Types
Type V
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Types
Type VI
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 3Population: MITT population included all participants who were treated at both Baseline and Week 3.
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 3 were reported.
Outcome measures
| Measure |
Down-up
n=31 Participants
Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Top-down
n=29 Participants
Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
|---|---|---|
|
Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3
Very Much Improved
|
18 Participants
|
12 Participants
|
|
Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3
Much Improved
|
10 Participants
|
8 Participants
|
|
Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3
Improved
|
3 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: At Week 6Population: MITT population included all participants who were treated at both Baseline and Week 3. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 6 were reported.
Outcome measures
| Measure |
Down-up
n=30 Participants
Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Top-down
n=29 Participants
Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
|---|---|---|
|
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6
Very Much Improved
|
56.7 Percentage of participants
|
75.9 Percentage of participants
|
|
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6
Much Improved
|
36.7 Percentage of participants
|
17.2 Percentage of participants
|
|
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6
Improved
|
6.7 Percentage of participants
|
6.9 Percentage of participants
|
PRIMARY outcome
Timeframe: At Week 9Population: MITT population included all participants who were treated at both Baseline and Week 3. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 9 were reported.
Outcome measures
| Measure |
Down-up
n=30 Participants
Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Top-down
n=28 Participants
Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
|---|---|---|
|
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9
Very Much Improved
|
76.7 Percentage of participants
|
71.4 Percentage of participants
|
|
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9
Much Improved
|
20.0 Percentage of participants
|
17.9 Percentage of participants
|
|
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9
Improved
|
3.3 Percentage of participants
|
10.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 3, 6, and 9Population: MITT population included all participants who were treated at both Baseline and Week 3. Here, "number analyzed" signifies participants who were evaluable for this outcome measure at specified timepoints.
The treating investigator assessed the naturalness of the treatment result based on review of baseline photographs and live assessment on how much they agreed or disagreed to the statement as follows: "The treatment results were natural looking". The investigator's questionnaire for naturalness of the treatment result were categorized into "strongly agree, agree, neither agree or disagree, disagree and strongly disagree". The percentage of participants with naturalness of the treatment result as assessed by treating investigator were reported.
Outcome measures
| Measure |
Down-up
n=31 Participants
Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Top-down
n=29 Participants
Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
|---|---|---|
|
Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
Naturalness at Week 9: Strongly agree
|
73.3 Percentage of participants
|
89.3 Percentage of participants
|
|
Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
Naturalness at Week 3: Strongly agree
|
90.3 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
Naturalness at Week 3: Agree
|
9.7 Percentage of participants
|
10.3 Percentage of participants
|
|
Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
Naturalness at Week 6: Strongly agree
|
90.0 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
Naturalness at Week 6: Agree
|
10.0 Percentage of participants
|
10.3 Percentage of participants
|
|
Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
Naturalness at Week 9: Agree
|
26.7 Percentage of participants
|
10.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 3, 6 and 9Population: MITT population included all participants who were treated at both Baseline and Week 3. Here, "number analyzed" signifies participants who were evaluable for this outcome measure at specified timepoints.
Participants completed 7 questions of subject satisfaction Questionnaire which are listed as follows: a) My first treatment improved my appearance, b) Compared to my first treatment, treating both areas in combination improved appearance, c) I am satisfied with the contour of my lower face after treatment, d) I am satisfied with the shape of my chin, e) I am satisfied with how well defined my chin looks, f) I feel more attractive after treatment, g) I feel comfortable being photographed. SSQ was balanced on 5-point scale assessing subject satisfaction with study treatment. Possible scores range was 1-Very Satisfied, 2-Satisfied, 3-Neither satisfied nor dissatisfied, 4-Dissatisfied, 5-Very Dissatisfied. Percentage of participants who strongly agreed or agreed to the SSQ were reported.
Outcome measures
| Measure |
Down-up
n=31 Participants
Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Top-down
n=29 Participants
Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
|---|---|---|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
My first treatment improved my appearance at Week 3
|
100 Percentage of participants
|
93.1 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
My first treatment improved my appearance at Week 6
|
93.3 Percentage of participants
|
93.1 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
My first treatment improved my appearance at Week 9
|
96.7 Percentage of participants
|
89.3 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I am satisfied with the contour of my lower face after treatment at Week 3
|
96.8 Percentage of participants
|
79.3 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I am satisfied with the contour of my lower face after treatment at Week 6
|
96.7 Percentage of participants
|
93.1 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I am satisfied with the contour of my lower face after treatment at Week 9
|
100 Percentage of participants
|
96.4 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I am satisfied with how well-defined my chin looks at Week 3
|
93.5 Percentage of participants
|
37.9 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I am satisfied with how well-defined my chin looks at Week 6
|
93.3 Percentage of participants
|
86.2 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I am satisfied with how well-defined my chin looks at Week 9
|
96.7 Percentage of participants
|
89.3 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I feel more attractive after treatment at Week 3
|
80.6 Percentage of participants
|
72.4 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I feel more attractive after treatment at Week 6
|
93.3 Percentage of participants
|
75.9 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I feel more attractive after treatment at Week 9
|
90.0 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I feel comfortable being photographed at Week 3
|
77.4 Percentage of participants
|
55.2 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I feel comfortable being photographed at Week 6
|
86.7 Percentage of participants
|
75.9 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I feel comfortable being photographed at Week 9
|
90.0 Percentage of participants
|
78.6 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
Compared to my first treatment, treating both areas in combination improved my appearance at Week 6
|
100.0 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
Compared to my first treatment, treating both areas in combination improved my appearance at Week 9
|
100.0 Percentage of participants
|
92.9 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I am satisfied with the shape of my chin at Week 3
|
96.8 Percentage of participants
|
41.4 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I am satisfied with the shape of my chin at Week 6
|
96.7 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
I am satisfied with the shape of my chin at Week 9
|
100.0 Percentage of participants
|
92.9 Percentage of participants
|
Adverse Events
Down-up
Top-down
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Down-up
n=32 participants at risk
Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
Top-down
n=29 participants at risk
Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection.
|
|---|---|---|
|
General disorders
Implant site bruising
|
3.1%
1/32 • Number of events 1 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
6.9%
2/29 • Number of events 2 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
|
General disorders
Implant Site Pain
|
18.8%
6/32 • Number of events 6 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
10.3%
3/29 • Number of events 3 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
|
General disorders
Implant site swelling
|
3.1%
1/32 • Number of events 1 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
3.4%
1/29 • Number of events 1 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
|
Infections and infestations
Influenza
|
3.1%
1/32 • Number of events 1 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
0.00%
0/29 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
3.4%
1/29 • Number of events 1 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/32 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
3.4%
1/29 • Number of events 1 • From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER